A: Yes, on May 8, 2020 the FDA gave the Emergency Use Authorization (EUA) to the Quidel Corporation for their Sofia 2 SARS Antigen FIA. The EUA was granted for point-of-care which automatically makes it acceptable for a CLIA waived laboratory. This test requires the use of Quidel’s Sofia 2 device or other approved devices and can produce results in 15 minutes. One caveat with this procedure is that negative results should be treated as presumptive and confirmed with a molecular assay. Read more about the FDA authorization. See the package insert for instructions and limitations.
A: This CMS document provides recommendations to limit those medical services that could be deferred, such as non-emergent, elective treatment and preventive medical services for patients of all ages. Be aware that some states and municpalities have enacted executive orders with stricter guidelines and definitions of non-essential medical services. If you have questions, check with your state or loacal government websites and/or Board of Medical Examiners.
Please see the section on Re-opening/Re-starting for further information.
A: We have developed two sample letters for use in directing your patients on how you are handling the Coronavirus situation. These are templates which must be customized to your situation. We advise all practices to review your policies and educate your staff as you consider system changes.
A: These regulations have been considerably loosened during the Public Health Emergency, but we recommend you check your state's individual situation.
A: With the rapid emergence of waivers and relaxing of laws related to the Coronavirus epidemic, there are scammers already trying to take advantage of the situations. This site keeps Compliance Officers up-to-date on the OIG's guidance's and FAQs.
A: Section 1135 Medicaid Waivers, at least 23 states have approved waivers. The list at this site gives State specific information.
A: Each state has different rules surrounding this. Find the information for your state here.
A: This document provides a comprehensive list of and links to the flexibilities that CMS has implemented to fight COVID-19. This includes Telehealth services, Workforce issues and Stark Law waivers.